{
    "info": {
        "nct_id": "NCT03005860",
        "official_title": "A Prospective, Randomized, Controlled Trial to Compare the Effect of TIVA Propofol vs Sevoflurane Anaesthetic on Serumserum Biomarkers and on PBMCs in Patients Undergoing Breast Cancer Resection Surgery",
        "inclusion_criteria": "1. Women with histopathologically (biopsy/FNAC) proven breast carcinoma with Resectable disease (T 1-4, N 0-1, M 0) [Stage I-III].\n2. Willing for upfront modified radical mastectomy.\n3. ASA Physical Status 1-2\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. use of morphine or on steroid therapy upto 3 months before surgery;\n2. history of substance abuse or cognitive dysfunction;\n3. endocrine disorders- diabetes, hypothyroid;\n4. history of HIV, Hep-B or Hep-C infections;\n5. Contraindication to analgesics or anaesthetic drugs;\n6. Pregnant & lactating women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Women with histopathologically (biopsy/FNAC) proven breast carcinoma with Resectable disease (T 1-4, N 0-1, M 0) [Stage I-III].",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "histopathologically (biopsy/FNAC) proven breast carcinoma",
                    "criterion": "breast carcinoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "biopsy",
                                "FNAC"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Resectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "T 1-4",
                    "criterion": "tumor size (T)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N 0-1",
                    "criterion": "lymph node involvement (N)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M 0",
                    "criterion": "metastasis (M)",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I-III",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Willing for upfront modified radical mastectomy.",
            "criterions": [
                {
                    "exact_snippets": "Willing for upfront modified radical mastectomy.",
                    "criterion": "willingness for upfront modified radical mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ASA Physical Status 1-2",
            "criterions": [
                {
                    "exact_snippets": "ASA Physical Status 1-2",
                    "criterion": "ASA Physical Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. use of morphine or on steroid therapy upto 3 months before surgery;",
            "criterions": [
                {
                    "exact_snippets": "use of morphine",
                    "criterion": "morphine use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "up to 3 months before surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "on steroid therapy",
                    "criterion": "steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "up to 3 months before surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. history of substance abuse or cognitive dysfunction;",
            "criterions": [
                {
                    "exact_snippets": "history of substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cognitive dysfunction",
                    "criterion": "cognitive dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. endocrine disorders- diabetes, hypothyroid;",
            "criterions": [
                {
                    "exact_snippets": "endocrine disorders- diabetes",
                    "criterion": "endocrine disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "diabetes"
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrine disorders- ... hypothyroid",
                    "criterion": "endocrine disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "hypothyroid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. history of HIV, Hep-B or Hep-C infections;",
            "criterions": [
                {
                    "exact_snippets": "history of HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... Hep-B",
                    "criterion": "Hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... Hep-C",
                    "criterion": "Hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Contraindication to analgesics or anaesthetic drugs;",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to analgesics",
                    "criterion": "analgesics",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to ... anaesthetic drugs",
                    "criterion": "anaesthetic drugs",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Pregnant & lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}